Clearance Summary
NONCON ROBO PACHY F&A received FDA 510(k) clearance under submission number K062763, sponsored by Konan Medical, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-02-22.
- Submission: K062763
- Applicant / Sponsor: Konan Medical, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2008-02-22
Classification & Regulation
This clearance is catalogued under FDA product code NQE and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.